Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I thank the House for providing the opportunity to provide an update on matters relating to CervicalCheck, to speak about the progress that has been made to respond to the issues raised while driving continued improvement in the service, and to respond to questions Deputies may have.

Crucially, the screening service has continued to focus on continuation of a programme which, despite the failings which emerged, has reduced the burden of cervical cancer for women in Ireland. Cervical screening saves lives, and we must and will keep that at the forefront of our minds. Members will be very conscious of the impact of this disease and of non-disclosure on the 221 women and families affected. Supporting these women and families has been a priority for me, and the Government decided to ensure that a package of primary and social care supports would be made available to this group. The HSE now has an established and stable process in place to ensure that these supports are being provided.

In December, the Government agreed to establish an independent statutory tribunal, chaired by Ms Justice Mary Irvine, to deal with claims arising from CervicalCheck. My Department is working on drafting heads of a Bill, and this is a Government priority and therefore is included in the spring legislative programme. I will also shortly seek Government approval for the establishment of a non-statutory scheme to provide ex gratiapayments for the women affected by the non-disclosure of the audit. This will be an important development where the State will accept its responsibility in respect of non-disclosure and make ex gratiapayments to the women and families affected.

Separately, the independent expert panel review, which is being carried out by the Royal College of Obstetricians and Gynaecologists, will provide much-needed clarity and independent clinical assurance to the women involved. More than 1,000 women have consented to be included in the review, or approximately 63% of those eligible to participate. This is a very welcome level of participation and allows for a robust and comprehensive aggregate report to be provided. There will be an individual report for each woman. I am pleased to say that the transfer of slides for the cytology phase of the review has begun.

When the issues first arose in connection with CervicalCheck, the Government acted quickly and worked with the Opposition to establish a scoping inquiry led by Dr. Gabriel Scally, a renowned expert in public health. I must acknowledge that it was with the input of Oireachtas members that the scoping inquiry and its terms of reference were established. With his report, Dr. Scally brought much-needed clarity to the CervicalCheck issues and also to the limitations of screening and audit. This clarity and understanding is crucial if we are to address effectively what went wrong. In September, when I brought the report to Government, I committed to returning to Government within three months with an implementation plan for all of Dr. Scally's recommendations. In December, following Government approval and Dr. Scally's consideration and analysis of the implementation plan, I published it with 126 actions for all 50 of these recommendations. These actions cut across a wide range of relevant areas, women's health, the issue of organisation and governance, laboratory services and procurement, open disclosure, cancer registration, other screening programmes, and resolution. My Department, the HSE and the National Cancer Registry of Ireland, in particular, all have important work to do on implementing these actions.

I am very pleased to report that Dr. Scally has reviewed the plan and commended the commitment it shows as well as the work done to date. This level of independent scrutiny provides very welcome assurance about the plan, which sets out an ambitious programme of work and a necessary one. Dr. Scally said to me last week that this is the first time he has been asked to oversee the implementation of recommendations from a report he has done on something that went wrong. He very much welcomes that involvement and I am very grateful for it. I intend to publish updates regularly on progress on implementing these actions, and in fact implementation of many of these recommendations is under way.

The establishment of a new independent patient safety council is a key action in the Scally implementation plan. Its first priority will be to undertake a review of all open disclosure policies, so that one approach is consistently applied across the whole health landscape, and that we put in place an optimum environment for the operation of open disclosure. The proposed membership and terms of reference of the independent patient safety council are being progressed as a matter of priority. It will include strong patient and public representation and international patient safety expertise. In addition, there can be absolutely no ambiguity about informing patients of serious adverse events. That is why, in bringing forward the patient safety Bill, we are providing for mandatory open disclosure and mandatory reporting of serious incidents. This Bill was approved by the Government in July, and in September underwent pre-legislative scrutiny in the Oireachtas Joint Committee on Health. It is currently undergoing drafting, and I want to be in a position to introduce it into the Oireachtas as soon as possible.

A further key priority is the establishment of a national screening committee this year, and my Department is actively engaging with the UK National Screening Committee as part of informing the process of establishing this committee. Dr. Scally has committed to providing a supplementary report into certain further aspects of the laboratories such as procurement, quality and accreditation arrangements, and governance structures. I expect to receive Dr. Scally's further report in the coming weeks, and it is my intention to give full and detailed consideration to any further recommendations it provides.

Members will recall that Dr. Scally provided valuable assurance on the quality management processes in our existing labs, and the HSE negotiated tirelessly in complex circumstances to ensure extension of laboratory contracts to allow for continuation, which was crucial for Irish women. We could not have had a situation where the screening programme stopped. In tandem, the HSE has been working to address the significant capacity issues we have following on from the much greater levels of screening in 2018. This is an issue that will take time to resolve, and I have always been clear on that. It is not a question of additional resources. If that were the solution, we would not have a problem. There is a global challenge in cytology capacity which impedes the HSE's ability to source additional capacity easily. The key priority now is to address the backlog and stabilise the programme, and the HSE is developing a capacity plan which I hope to receive in the very near future.

I want to take a moment to contradict assertions made in this House with regard to my decision to offer women the opportunity of a free repeat smear test where their GPs felt it was appropriate. It is not the case that I was advised against this decision; quite the contrary. I have set out the rationale for and context of this decision many times. Many thousands of women contacted the CervicalCheck helpline. Requests for additional supports and reassurance were considered in this context, including the provision of an opportunity for a GP consultation for women who wished to discuss their request for a repeat smear. GPs also contacted me about this, and the offer was welcomed at the time by Deputies on both sides of the Oireachtas. A fee to provide for this free repeat smear was agreed with the Irish Medical Organisation. This was discussed with and agreed by my senior officials, including the Chief Medical Officer, at the end of April and was followed by a Government decision on 1 May. To those who persist in saying that I acted against official advice, that is incorrect. They have misled the Dáil and stated incorrect information on the record of the Dáil. They need to stop doing that because it is not helpful in assuring women of the decision-making process that we all took in good faith.

The level of uptake shows that many women were seeking this reassurance. However, the backlog which has arisen is not solely due to the repeat smears but also, and this is a welcome development, because of an increased uptake in the programme generally. I have acknowledged many times, including in this House, the difficulty of the backlog, of which there is no doubt, and the priority with which this is being treated. It has also been asserted that I ended the provision of free repeat smear tests in December because of issues related to the expiry of tests. This was said on the record of this House. This is also untrue. I approved the cessation of the free out-of-cycle smears in October, at which point the HSE, as it was responsible for the operation of the system, proposed that as tests would at that stage be scheduled into December, the arrangements would run to the end of the year. I followed official advice on the cessation of the programme post the publication of the Scally report. I followed that advice in October with a programme of repeat smears ending in December.

I want to clarify again that the backlog is separate to the issue which has arisen with Quest and secondary HPV testing. It relates to cervical smear tests where secondary HPV testing is required and the timeframe within which that secondary test should take place. Of the approximately 500,000 samples tested by Quest since 2015, the HSE has advised that some HPV tests have been performed outside of the recommended 30 day timeframe in that laboratory. The HSE advises that, subject to final confirmation, approximately 4,600 women are being called for a retest, and that the vast majority of letters to these women have now issued. The director general of the HSE put information on the record of the Joint Committee on Health this morning. The HSE has advised that clinical research shows that HPV tests remain effective even when they are performed outside the recommended timeframe and that there is little risk of inaccuracy due to the issue that Quest has identified. Indeed Dr. Peter McKenna has said on the record and in the media many a time that the clinical risk was exceedingly low. These tests will be processed by the laboratory as a priority.

Last week I had the honour and privilege of spending much of the afternoon and evening with the wider 221+ patient advocacy group.

I was very glad to have an opportunity to meet with the group face-to-face and to listen to its members. I sincerely thank them for taking the time to attend in large numbers, for telling me their stories and experiences and for sharing information about their personal lives in order that they can be sure that my officials and I have the best possible understanding of the impact of this awful disease and of non-disclosure on their lives. This meeting and all of my interactions with affected women and families underlined for me the need to keep the interests and health of the women of Ireland to the forefront of all our minds. I know that is a goal we share. This is why my focus is, and will firmly remain, on supporting these women and families and on the continuation and improvement of the cervical screening programme. We can and must make it our aim to effectively eradicate this awful disease. We can do that through the measures we are taking here and the measures we will take together.

See this speech in context